Annuloplasty ring delivery system

ABSTRACT

An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line. The assembly further includes a mechanism for releasably binding the suture guide to the surface of the holder and a detachable handle extendibly attached to the holder by means of a lanyard so that the handle can be detached to afford an unobstructed view of the surgical site, but cannot be removed from the surgical site until the holder has also been removed.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.09/800,074, filed Mar. 6, 2001, now issued as U.S. Pat. No. 6,558,416,which is a continuation of U.S. patent application Ser. No. 09/085,944,filed May 27, 1998, now issued as U.S. Pat. No. 6,283,993, which is acontinuation of U.S. patent application Ser. No. 08/902,654, filed Jul.30, 1997, now abandoned, which is a continuation of U.S. patentapplication Ser. No. 08/474,048, filed Jun. 7, 1995, now issued as U.S.Pat. No. 5,683,402, which is a continuation of U.S. patent applicationSer. No. 08/190,755, filed Feb. 2, 1994, now issued as U.S. Pat. No.5,496,336, which is a divisional of U.S. patent application Ser. No.08/004,214, filed Jan. 13, 1993, now issued as U.S. Pat. No. 5,290,300,which is a continuation of U.S. patent application Ser. No. 07/739,925,filed Aug. 2, 1991, now abandoned, which is a continuation-in-part ofU.S. patent application Ser. No. 07/387,909, filed Jul. 31, 1989, nowabandoned, and a continuation-in-part of U.S. patent application Ser.No. 07/444,189 filed on Nov. 30, 1989, now issued as U.S. Pat. No.5,041,130.

BACKGROUND OF THE INVENTION

During surgical repair of an organ or other body part, the surgeontypically makes an incision to open the organ. Upon closure of thesurgical wound, sutures are placed in the various layers of tissue todraw the two edges of the wound together so that the healing process canreform a smooth and competent surface. However, sutures often tearthrough the tissue if they are subjected to stress, thus damaging thesurgical closure of the wound. It would be desirable in many instancesto have a means for lending permanent support to strengthen and supportthe wall of the organ into which the surgical incision has been placed.Alternatively, in many instances it would be preferred to have abiodegradable suture guide.

In many cases, the incision is not a straight line, but is shaped toconform to an anatomical requirement, making it difficult for thesurgeon to balance the tension on the sutures to form the desired shape.In a number of instances the suture line is substantially curvilinearand it is of utmost importance that the suture line maintain apredetermined dimension. For example, when two blood vessels, or othervessels, such as intestines, are sutured together, the need exists forsome means of preventing the suture line from constricting the vessel soas to create a potential point of blockage. Similar problems ariseduring bowel and bronchial resection. As another example, when thesurgeon is reducing the size of a stomach by surgical means, the needexists for a means to assure that the reshaped organ will have aparticular circumferential dimension and that the pleats used to reducethe size of the organ are evenly distributed so as to avoid formation ofareas of reduced flexibility along the suture line. In other situations,such as in cosmetic surgery, the surgeon may desire to assure that thesuture line is limited to a predetermined length.

In all of these situations, it is desirable to use a suture guide to aidthe surgeon in achieving the desired dimension of the surgical closureand/or to rigidly support the area where the sutures are placed, thusavoiding the danger that the sutures will tear through the tissue orthat the suture line will act like a draw string and undesirably bunchup the tissue.

These problems are particularly acute in the surgical procedure known asannuloplasty wherein any of a number of types of prostheses have beenused in surgical correction of deformed mitral or bicuspid heart valves.

Diseases and certain natural defects to heart valves can impair thefunctioning of the cusps of the valves in preventing regurgitation ofblood from the ventricle into the atrium when the ventricle contracts.For example, rheumatic fever and bacterial inflammations of the hearttissue can distort or dilate the valvular annulus, thus resulting indisplacement of the cusps away from the center of the valve and causingleakage of blood during ventricle contraction.

Two techniques, generally known as annuloplasty, are used to reshape thedistended and/or deformed valve annulus. In the technique known as“plication,” the circumference of the valve annulus is reduced byimplanting a rigid or semi-rigid prosthetic ring of reducedcircumference about the base of the annulus while the annulus is pleatedto reduce its circumference to that of the ring. In the technique knownas “reconstruction”, the circumference of the annulus is not reduced,but the annulus is restructured into an elongate shape. To accomplishthis goal, a rigid or semi-rigid ring having the same circumference asthe annulus but in an elongate or elliptical shape is surgicallyimplanted about the base of the valve. Both plication and restructuringare intended to eliminate the gap in the closure of the distended valveby bringing back together the tips of the valve cusps.

Many different types of prostheses have been developed for use inannuloplasty surgery. In general, prostheses are annular or partiallyannular shaped members that fit about the base of the valve annulus.Initially the prostheses were designed as rigid frame members, or“rings”, of metallic or other rigid materials that flex little, if atall, during the normal opening and closing of the valve. Since a normalheart valve annulus continuously flexes during the cardiac cycle, arigid ring prosthesis interferes with this movement and therebyrestricts movement of the valve itself. Sutures used to implant rigidring prostheses consequently undergo stresses sufficient to tear thesutures loose. Examples of rigid annuloplasty ring prostheses aredisclosed in U.S. Pat. No. 3,656,185, issued to Carpentier on Apr. 18,1972; and U.S. Pat. No. 4,164,046, issued to Cooley on Aug. 14, 1979.

Others have suggested the use of completely flexible annuloplasty ringprostheses. Examples of completely flexible ring prostheses aredisclosed in U.S. Pat. No. 4,290,151, issued to Massana on Sep. 22,1981, and are discussed in the articles of Carlos D. Duran and Jose LuisM. Ubago, “Clinical and Hemodymanic Performance of a Totally FlexibleProsthetic Ring for Atrioventricular Valve Reconstruction”, 5 Annals ofThoracic Surgery, (No. 5), 458-463, (November 1976) and M. Puig Massanaet al, “Conservative Surgery of the Mitral Valve Annuloplasty on a NewAdjustable Ring”, Cardiovascular Surgery 1980, 30-37, (1981).

Flexible prostheses generally include an inner support member formedfrom a flexible material. This support member is wrapped in woven,biocompatible cloth material. Realignment of the valve cusps duringopening and closing of the valve is obtained by the proper suturing ofthe ring about the valve annulus. However, completely flexible ringprostheses provide almost no support to the suture area during theprecarious implant procedure. Even though the surgeon attempts to evenlydistribute the sutures along the periphery of the valvular annulus,during implant the drawstring effect of the sutures tends to bunch thematerial covering the flexible ring so that the sutures also bunchtogether at localized areas around the ring. This phenomenon, known asmultiple plications in the heart valve annulus, causes rigid areasaround the annulus. Thus, the flexible ring actually ends by impartingareas of rigidity and thereby distorts the valve annulus during theopening and closing of the valve despite the desired reduction incircumference of the valvular annulus.

To overcome some of the drawbacks of rigid ring prostheses, stillfurther types of annuloplasty prostheses have been designed to allow foradjustment of the ring circumference, either by the surgeon duringimplant, or automatically as the implanted ring moves during the openingand closing of the valve. This type of adjustable prosthesis istypically designed in combination with a rigid, or at least partiallyrigid, frame.

An example of a self adjusting ring prosthesis is taught in U.S. Pat.No. 4,489,446, issued to Reed on Dec. 25, 1984. To provide for selfadjustment of the prosthetic annulus, two reciprocating rigid metalpieces form the frame. U.S. Pat. No. 4,602,911, issued to Ahnadi et al.and U.S. Pat. No. 4,042,979, issued to Angell on Aug. 23, 1977, providefurther adjustable ring protheses having a mechanism for adjusting thecircumference of the ring. But due to rigidity of the frame members, theself-adjusting prostheses do not overcome many of the disadvantages ofother types of rigid ring prostheses.

U.S. Pat. No. 4,055,861, issued to Carpentier on Nov. 1, 1977, teachesan annuloplasty ring prosthesis having a flexibility between thecompletely flexible rings discussed above and the various types of rigidring. The ring of Carpentier is deformable to an equal degree andsimultaneously in all directions and preferably has the elasticity of anannular bundle of 2 to 8 turns of a cylindrical bristle of poly(ethyleneterephthalate).

While rigid and semi-rigid annuloplasty rings eliminate the bunchingcaused by flexible rings, the restrictive nature of such rings isgenerally detrimental to the valve's ability to open and close normally.It thus remains an object of the invention to provide a surgical meansfor reshaping a deformed or dilated heart valve annulus having none ofthe above described drawbacks associated with known annuloplasty ringprostheses.

For use in annuloplasty of heart valves, as in other applications, it isdesirable that a suture guide be entirely flexible, light weight, andcompliant while having sufficient strength to withstand stress placedupon the sutures sewn through and around it. However, an entirelyflexible suture guide cannot prevent bunching of the tissue in thedraw-string effect described above and thus cannot assure that thesuture line and the tissue into which it is placed will maintain anydesired dimension, for example, a desired circumference. Therefore theneed exists for a means of temporarily providing rigidity and fixeddimension to the suture guide during the surgery, but rendering thesuture guide freely flexible once the surgery has been accomplished.

DESCRIPTION OF THE DRAWINGS

The present invention may be better understood and the advantages willbecome apparent to those skilled in the art by reference to theaccompanying drawings, wherein like reference numerals refer to likeelements in the several figures, and wherein:

FIG. 1 is a perspective exploded view of a flexible suture guide mountedon a rigid holder assembly in accordance with an embodiment of theinvention.

FIG. 1A is a top view in partial cross-section of a length of a flexiblesuture guide in accordance with the present invention.

FIG. 1B is a top view in partial cross-section of the flexible sutureguide of the present invention sutured into a ring configuration.

FIG. 2 is an exploded view of the guide mount portion and lower part ofthe handle portion of the holder assembly of FIG. 1 without the sutureguide.

FIG. 3 is a perspective view of a flexible suture guide of the presentinvention mounted on the assembled guide mount and lower handle portionsseen in FIG. 2.

FIG. 4 is a cross-sectional view of the assembled guide mount and lowerhandle portions of FIG. 3 along line 4—4.

FIG. 5 is a top view of the guide mount seen in FIG. 3 with a flexiblesuture guide tautly secured thereto.

FIG. 6 is a perspective view of a guide mount in accordance with anotherembodiment of the invention.

FIG. 7 is a cross-sectional view of a suture guide having a lenticularcross-sectional shape in accordance with another embodiment of theinvention.

FIG. 8 is a side perspective sectional view of a handle assembly inaccordance with another embodiment of the invention.

FIG. 9 is a bottom view of the handle extension of FIG. 8.

FIG. 10 is a top view of the housing of FIG. 8.

FIG. 11 is a perspective view of a suture guide holder in accordancewith another embodiment of the invention.

FIG. 12 is an exploded view of the guide mount portion and lower handleportion of the suture guide holder of FIG. 11.

FIG. 13. is a top view of the guide mount portion of the suture guideholder of FIG. 11.

FIG. 14 is a perspective view of a linear suture guide holder inaccordance with another embodiment of the invention.

FIG. 15 is a perspective view of the suture guide holder of FIG. 14 witha suture guide attached.

FIG. 16 is a perspective view of a circular suture guide holder inaccordance with another embodiment of the invention.

FIG. 17 is a perspective view of the suture guide holder of FIG. 16 witha suture guide attached.

FIG. 18 is a cross-sectional view of the suture guide and holder of FIG.17 taken along line 18—18.

SUMMARY OF THE INVENTION

The present invention overcomes the above discussed disadvantages byproviding an assembly for holding a substantially flexible suture guidein a substantially taut position for placing a suture line having apredetermined dimension. When attached to the holder assembly, theflexible suture guide assumes a shape or geometry, such as acircumference, that conforms to the shape or geometry of that portion ofthe body organ or vessel that is being sutured. The holder assembly canbe formed to hold the suture guide in any desired shape, whetherstraight, curvilinear, or a combination of the two and the suture guidecan be either biodegradable or permanently implantable. Thus the surgeonundertaking reconstructive surgery is aided in achieving a suture lineof any desired shape, geometry and/or dimension.

The assembly includes a holder portion having a surface against whichthe suture guide is positioned and held tautly in a fixed shape,geometry and/or dimension. More particularly, the holder assemblyincludes a body having an outwardly facing surface, generally flat,against which the suture guide is tautly positioned so that the sutureguide assumes the shape, geometry and/or dimension desired for thesuture line. Preferably, this surface is formed with at least onedepression for receiving a portion of the suture guide. The assemblyfurther includes a detachable handle and a mechanism for releasablybinding the suture guide to the surface.

The flexible suture guide used with the assembly of the inventioncomprises a generally elongated flexible body element having an internalflexible rib encased within a biocompatible covering, such as a wovencloth material. The suture guide can be formed of either biodegradableor non-biodegradable materials depending upon whether its purpose is toserve as a permanent support to prevent tearing out of the suturesplaced through it or whether the suture-supporting function is to be atemporary one. In addition to its function as a post-surgical supportfor sutures, during surgery when used in combination with the holderdisclosed herein, the suture guide serves as a rigid support andtemplate by which the surgeon controls the length of the finished sutureline. For instance, if the task is to suture together two ends of abowel from which a section has been removed, the combination of sutureguide and holder assure that the circumference of the surgical jointureis substantially similar to the circumference of the nearby regions ofthe colon, rather than smaller or larger.

Therefore, the holder device is designed to lend a temporary rigidity ortautness to the suture guide while lending to it a shape selected tofacilitate the suturing task. For instance, when the task is to place aline of sutures around the circumference of a curvilinear surface, theholder is designed to fit around at least a portion of the circumferencewhile holding the suture guide against the said circumference to aid thesurgeon in making a surgical jointure that does not distort the saidcircumference.

In use, the suture guide is releasably retained against the outwardlyfacing body surface by a means for releasable attachment, for exampleone or more threads, pieces of Velcro™, and the like, placed so that thesuture guide lies along and temporarily substantially assumes the shapeof the body. The means for attachment may also be a biodegradableadhesive having the capacity to firmly attach the suture guide to theholder body for sufficient time to complete the surgery, but having thecapacity to dissolve or be dissolved once the suture line has beenplaced. In one embodiment, the thread attaches the suture guide to thebody surface at least at two points, for example at its extreme ends, bypassing at least partially through the suture guide and about the body,i.e., by means of an in and out stitch or stitches.

The means for releasable attachment of the suture guide to the body mustbe such that the suture guide can be released from the body once thesuture line has been placed by the surgeon without disturbing thesutures sufficiently to cause dislocation or tearing of the suturesthrough the tissue. For example, if the means for releasable attachmentis one or more threads, a portion of the thread(s) affixing the sutureguide to the body can be positioned to be cut by scissors, or the like,to freely release the suture guide from the body. When the thread orthreads are cut or otherwise ruptured, the suture guide is freelyreleased from the body.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is directed to a holder assembly for holding asubstantially flexible, implantable suture guide in a substantially tautposition for suturing along a suture line having a desired shape ordimension, such as the desired circumference to which an enlarged heartvalve annulus is to be reduced by the formation of pleats about the baseof the valve annulus. The suture guide of the invention is formed from afreely flexible rib encased within a woven cloth covering. In use, theflexible suture guide of the invention is held taut by the holderassembly and in a configuration determined by the shape of the holderassembly while the surgeon uses the support provided by the taut sutureguide to evenly place the sutures and to draw the tissue by means of thesutures passed through the suture guide into a suture line having ashape substantially similar to that of the suture guide and holder. Forexample, for use in annuloplasty, the holder assembly can be C-shaped sothat the suture guide temporarily affixed thereto assumes a C-shapedconfiguration. The suture guide can then be sutured to the base of aheart valve annulus so as to restrict the circumference of a dilatedand/or deformed valve annulus to a more normal one. When the sutureguide is released from the holder, it will assume any shape that thatportion of the body organ or vessel assumes in accordance with thedynamic function of the organ or vessel.

Generally the guide mount assembly includes a guide support formed witha shape similar to that of the desired suture line, as in the aboveexample wherein the holder assembly is in the general shape of the valveannulus about which the suture guide is to be surgically placed toassist in holding pleats in the walls of the annulus. The suture guideis mounted along at least a portion of this guide support, for examplealong a straight or a curved portion.

The holder assembly allows the surgeon to properly position the sutureguide while the suture guide is used to draw the sutures and associatedtissue into the desired configuration during the suturing process. Thefreely flexible suture guide is given temporary rigidity during surgeryby the detachable holder assembly, thus lending precision to the surgeonin controlling the placement and location of the stitches in the sutureline. In an annuloplasty, for example, the potential for formingmultiple plications as the circumference of the valve annulus isadjusted is thus greatly reduced.

Referring now to FIG. 1A, the suture guide 10 is an elongate, flexiblemember of a predetermined dimension. Due to its flexibility, the lengthof suture guide 10 can be manipulated to assume any desired shape, ie.,circular, C-shaped, straight, curvilinear or a combination ofcurvilinear and straight segments. In FIG. 1B, suture guide 10 is shownas shaped into a ring by suturing the two ends together with sutures 11.As shown in FIG. 1A, suture guide 10 comprises a substantially flexibleinner rib 14 encased within covering 16.

Rib 14 comprises a flat, rod-like or tubular piece of biocompatibleresilient, flexible material, such as mylar or silicone rubber. Rib 14can also contain a substance opaque to x-rays, for example, about 10 to15 weight percent, preferably 13 weight percent, of barium sulfate sothat the location of the suture guide can be determined inpost-operative x-rays. The outer covering 16 is formed from anybiocompatible material having sufficient strength to serve as an anchorto sutures without tearing and sufficient flexibility to be formed intoa tight covering for rib 14 without restricting flexibility of sutureguide 10. Preferably, the outer covering 16 is a woven cloth having anap to encourage tissue ingrowth, for example a dacron velour. Thisouter covering 16 is tightly wrapped and sewn about frame 14 so as tocompletely encase it. The thickness of the outer cloth 16 is sufficientto allow the surgeon to pass a suture therethrough.

FIG. 1 shows an exploded view of one embodiment of a holder assembly towhich a suture guide is mounted, as seen generally at 12 and 10respectively. The holder assembly 12 includes a guide mount assembly 18and handle assembly 40 comprising a handle 42 and housing 44.

FIGS. 2 through 5 illustrate in greater detail the guide mount assembly18 and how the suture guide 10 is mounted thereon. Guide mount assembly18 includes a guide support 20. For illustrative purposes, the sutureguide assembly 18 here shown is one intended for use in plication of adistended heart valve annulus. Therefore facing edge of guide support 20is generally C-shaped or annular, having a shape and circumferentialdimension similar to that the surgeon desires to achieve in the humanheart annulus by means of annuloplasty surgery. More particularly,support 20 is generally lenticular, having a C-shaped portion 28, withits ends connected by a straight side 30.

The suture guide 10 is fitted into a groove or trough 32 located aboutthe curved C-shaped portion 28 of the guide support 20 Trough 32 isdimensioned to receive a portion of the suture guide 10, as best seen inFIG. 4. The positioning of the suture guide 10 within the trough 32conforms guide 10 to the shape of the guide support 20 while exposing asubstantial portion of the covering 16 outside of the trough 32 to allowthe surgeon to pass a suture therethrough.

In the embodiment shown in FIGS. 2-5, the guide mount assembly 18 alsoincludes a central support hub 22 to which the guide support 20 isattached by a multiplicity of integrally formed spokes, preferablythree, one of which is seen at 24. The arrangement of mount assembly 18including, in this instance, a curved guide support 20 with hub 22 andspokes 24, allows the surgeon to visually observe the heart valve duringthe suturing process. Central support hub 22 is formed with an annulargroove 36. This groove 36 is formed proximate that end 34 of hub 22opposite guide support 20, and defines a post member 38. That portion ofhub 22 remaining on the side of the groove 36 opposite the guide support20, and hub end 34, includes an inwardly tapering peripheral surface, asseen generally at 35. The hub 22 also includes an open bore 37 throughwhich is fitted a cylindrical plug 39. The plug 39 is dimensioned toextend out from both sides of the bore 37. The purpose of taperedsurface 35, and the plug 39 will be described hereinafter.

As is further seen in FIG. 1, the handle assembly 40 includes anelongated handle 42 having end 54 mounted to housing 44. While housing44 may be integrally formed at the end 54 of the post 42, preferably end54 is formed with outwardly facing threads that threadably mate withthreads formed along a surface of an opening 59 formed in the top of thehousing 44. The opposite end of post 42 is formed with an externaletched surface 52 to assist the surgeon in gripping post 42. In anotherembodiment, end 54 of post 42 and opening 59 of housing 44 can be formedso that end 54 can be press fit into opening 59.

Housing 44 is a thimble-shaped structure having a circular wall 60defining a cavity 46. As seen better in FIG. 4, cavity 46 is open at oneside, seen generally as opening 45. The inner surface of the circularwall 60 inwardly converges a short distance from the opening 45. Thecavity 46 is generally wide enough at the open side 45 to snugly receivehub 22, but the plug 39 extends sufficiently outward from hub 22 toprevent passage through open side 45 into cavity 46. Wall 60 is formedwith two J-shaped notches, seen at 48 and 49 in FIGS. 2 and 3. TheseJ-shaped notches 48 and 49 are formed and positioned to respectivelyreceive the ends of the plug 39 extending outward from the hub 22. Theshape of the notches 48 and 49 defines a landing 50 between the long andshort legs of each notch.

Handle assembly 40 is coupled to the guide mount assembly 18 byinserting end 34 of the hub 22 into the cavity 46, with one of theoutwardly extending ends of the plug 39 passing through a respective oneof the J-shaped notches 48 and 49. The tapered surface 35 of the hub 22engages the inwardly tapering surface of the wall 60. This causes aslight compression of the hub end 34, resulting in a spring force. Thespring force acts to restrain the movement of the outwardly extendingends of the plug 39 through the larger legs of the J-shaped notches 48and 49. Additional exertion moves the ends of plug 39 through the largerlegs of J-shaped notches 48 and 49, with rotation of handle 40 passingthe outward ends of plug 39 across the landings 50 and into the smallerleg of the J-shaped notches 48 and 49.

The spring force established by the slight compression of the hub end 34maintains the coupling between housing 44 and guide mount assembly 18.The handle 40 is decoupled from the guide mount assembly 18 by reversingthe described procedure.

One embodiment of the means for releasably attaching suture guide 10 toguide support 20 of guide mount assembly 18 is seen in FIG. 5. Guidesupport 20 is formed with two apertures 66 and 68 extending throughguide support 20 and communicating with groove 32. The exact positioningof apertures 66 and 68 is not critical. As illustrated, apertures 66 and68 are formed along the straight portion of guide support 20, at alocation proximate two of the spokes 24.

One end 71 of a cord or suture thread 70 is passed through one of theapertures, as illustrated hole 66, and tied off on guide support 20. Theother end 73 of suture 70 is passed through the body of suture guide 10from one end to the other. This end 73 is then passed first through hole68 and then through and tied off at hole 66. After suture guide 10 issutured into position during surgery, i.e., about the valve annulus,that portion of the suture 70 between apertures 66 and 68 is snipped orcut in two. Suture 70 passes out of suture guide 10 by withdrawing thehandle assembly 12.

In accordance with another embodiment (not shown), the first end 71 istied off at hole 66, with the second end 73 passed first through one endof the suture guide 10, and then brought back across and passed throughthe other end of suture guide 10, through hole 68 and again tied off athole 66. Removal of suture 70 is accomplished by snipping the suture intwo at any point between the two holes and withdrawing it.

An alternative embodiment of the guide mount assembly 80 as seen in FIG.6 includes a guide support 82 having an open C-shaped side 84 but nostraight side joining the ends of the C. Except for the stateddifference in shape of the guide support 82, guide mount assembly 80 inFIG. 6 includes elements similar to those described for the suture guideof FIG. 5 (as is indicated by the prime of the previously providedelement number), and will be described in no further detail herein. Inthis embodiment of guide mount assembly 80, the means for releasablyattaching the suture guide to the guide support is a suture (not shown)positioned by tying off as described above across an open space betweenholes 68′ and 66′ (not shown).

In a preferred embodiment of the invention, the handle assembly 40 istethered to the guide mount assembly 18. As seen in FIG. 1, thistethering is performed by connecting one end of a lanyard, seengenerally at 100, to the handle assembly 40 and the other end of thelanyard 100 to the guide support 20, for instance to one of spokes 24.Lanyard 100 allows a surgeon to detach the handle assembly 40 from theguide support 20 during the suturing procedure to get a clearer view ofthe surgical site. By tethering handle 40 to the guide mount assembly18, the risk of the surgeon leaving the guide support 20 in the patientafter completion of the surgical procedure is greatly reduced. Lanyard100 also allows the surgeon to easily remove the guide support 20 afterthe handle has been detached.

In a still further preferred embodiment, a handle assembly 40 ismodified to house a spool of suture or string that acts like a tetherfor the guide mount assembly. The tether is attached at opposite ends tothe handle assembly and the guide mount assembly respectively andautomatically spools out of the handle assembly when the handle isdisconnected from the guide mount assembly.

This preferred embodiment is better seen in the several FIGS. 8 through10. The lower portion of a handle assembly in accordance with thisembodiment is seen in FIG. 8 at 90. Handle assembly 90 includes ahousing 92, a handle extension 94, and a handle post 96.

Housing 92 includes a pair of opposing J-shaped notches 98 and 99 thatfunction similarly to the J-shaped notches 48 and 49 described above.The handle extension 94 is fastened to the lower end of the handle post96 in any suitable manner. As shown, the handle extension 94 includes atone end a bore 102 for receiving the lower end 104 of the handle post96. End 104 of the handle post may be held in bore 102 by welding,stamping, or by providing the respective members with interlockingthreaded surfaces. Accordingly, neither of these structures of thehandle assembly 90 will be discussed in any greater detail.

The main distinction to the previously described embodiment is that thehandle assembly 90 is formed to carry a spool of suture, seen generallyat 106. This suture spool 106 is housed in a bore 112 formed in thehandle extension 94. Handle extension 94 and housing 92 are formed toreleasably fit together. Handle extension 94 and housing 92 includemating collars 108 and 110, respectively. Collar 108 is formed with agroove 114 that receives a tongue 116 extending upward from collar 110.Tongue 116 is formed with a central aperture 122, and two opposingcut-aways 118 and 120 that extend out in opposite directions from thisaperture 122.

Each of the collars 108 and 110 possesses four apertures. Apertures126-129 of collar 108 align with apertures 130-133 of collar 110 whenthe handle extension 94 and housing 92 are fitted together.

Suture spool 106 comprises a length of suture wound into a cylindricalconfiguration along lower end 104 of handle post 96, which fits intobore 112. The opposite ends of this suture length are tied to the tongue116 and the handle extension 94. One end of the suture is drawn throughthe central aperture of 122 and tied to tongue 116, as seen at 115. Theopposite end of the suture is drawn through an opening 124 extendingfrom the bore 112 through the handle extension 94 and is tied around thehandle extension 94, as seen at 117. It should be noted that for thepurpose of this invention, the meaning of the term “suture” shallinclude any cord, string or filamentous material useful for tetheringthe housing 92 to the handle extension 94.

Handle extension 94 and housing 92 are fitted together by placing thetongue 116 into the groove 114. Sutures are run through alignedapertures to hold the handle extension 94 and housing 92 together. Forexample, one suture 134 is passed through apertures 126 and 127 ofhandle extension 94 and apertures 130 and 131 of housing 92, while asecond suture 136 is passed through apertures 128 and 129 of handleextension 94 and apertures 132 and 133 of housing 92.

The handle assembly 90 of this embodiment is coupled to the guide mountassembly 18 as stated above. The handle post 96 is removed from thehousing 92 by cutting the sutures 134 and 136 and pulling the handleextension 94 away from the housing 92. Pulling away the handle post 96unravels the suture spool 106. After the suture guide is sutured intoposition along the suture line, i.e., about a heart valve annulus, thesuture(s) holding the guide mount assembly to the suture guide is cut.The guide mount assembly is then removed by pulling on the handle post96.

In another embodiment of the invention, shown in FIGS. 11-13, handleassembly 140 is also modified to house a spool of suture or string thatacts like a tether for the guide mount assembly 142. Referring to FIG.11, handle assembly 140, includes housing 144, handle post 146, and anenlarged handle portion 148. Handle post 146 is preferably made of amalleable metal or other material that allows the surgeon to bend thehandle to the desired angle while using the suture guide holderassembly. The enlarged handle portion 148 allows the surgeon to grip thehandle more easily and also makes it easier for the surgeon to maneuverthe suture guide holder into the surgery site. Housing 144 is releasablyattached to guide mount 150 as will be described in more detail withreference to FIG. 12. Suture guide 152 is releasably attached to guidemount 150 by threads or sutures (not shown) in a manner which will bedescribed with reference to FIG. 13.

Referring to FIG. 12, housing 144 includes bore 154 for receiving handlepost 146. The end of handle post 146 may be held in bore 154 by a pressfit or friction fit, by welding, or by providing the respective memberswith interlocking threaded surfaces. Housing 144 also includes a pair ofopposing slots 156 for receiving dog ears 158 of the suture spool 160.Suture spool 160 includes a length of suture or thread 162 wound into acylindrical configuration along spindle post 164. One end of the suture162 is tied to an aperture (not shown) in upper end 166 of suture spool160. The other end of suture 162 is affixed to hub 168 of guide mount150. Specifically, suture 162 passes down through aperture 170, upthrough aperture 172, and is tied off at aperture 172. The lower end ofspindle post 164 has a pair of opposing notches 174 formed therein whichare sized to be received by bore 176 of hub 168. Spindle post 164,therefore, is press fit or friction fit into bore 176.

Suture spool 160 is housed within the interior cavity (not shown) ofhousing 144 and is held in place when dog ears 158 snap fit intoopposing slots 156. Housing 144 with suture spool 160 in place is thenreleasably attached to guide mount 150 by sutures or threads 178 and 180shown in FIG. 11. Suture 180 passes through a pair of apertures 182 inhousing 144 and a pair of apertures 184 in guide mount 150 asillustrated by dotted lines 186 in FIG. 12. Suture 178 passes through apair of apertures 188 in housing 144 and a pair of apertures 190 inguide mount 150 as shown by dotted lines 192 in FIG. 12.

Once the suture guide and guide mount assembly has been placed at thesurgery site, the surgeon can remove the handle if desired by cuttingsutures or threads 178 and 180 at the location of the cutting guides 194and 196 shown in FIGS. 11 and 12. Cutting guides 194 and 196 consist ofa raised platform with a shallow groove 195 formed therein through whichthe suture passes and a deeper groove 197 formed in the platformperpendicular to the shallow groove through which scissors or othercutting tools can be inserted to clip or cut the suture at thatlocation. When the sutures are cut and the handle is removed, spool 160remains within housing 144 and suture 162 remains attached to hub 168.As the handle is pulled away from the guide mount, the suture or threadspools off spindle post 164 thereby providing a tether for removal ofthe guide mount after the suture guide has been detached from the guidemount and the surgery has been completed.

Referring to FIG. 13, suture guide 152 is releasably attached to guidemount 150 by sutures or threads 198, 200 and 202. Suture 198 is tied offat aperture 204 and then passes through one end of the suture guide andup through aperture 206 over cutting guide 208 down through aperture 206again, through suture guide 152, through aperture 209, then up throughaperture 210 where the other end of suture 198 is tied off. Suture 200is at one end tied off through aperture 210 and then passes under theguide mount 150 through aperture 211, through suture guide 152 and upthrough aperture 212, across cutting guide 214 and back down throughaperture 212. Suture 200 then passes through suture guide 152 again,through aperture 215 and up through aperture 216 where it is tied off.Finally, suture 202 is tied off at one end at aperture 216 and passesunder suture guide 150 through aperture 217, through suture guide 152,up through aperture 218, across cutting guide 220, down through aperture218 again where it passes through suture guide 152 and up throughaperture 222 where it is tied off.

Apertures 224 and 226 disposed in guide mount 150 at opposite ends ofthe suture guide 152 are used to temporarily attach each end of sutureguide 152 to each end of the guide mount 150 to hold the suture guide inplace during the process of threading sutures 198, 200 and 202 throughthe apertures of the guide mount and the suture guide. Once thethreading of sutures 198, 200 and 202 is complete, the sutures at 224and 226 are then removed. The sutures at 224 and 226 are shown forillustration purposes in FIG. 11 at 223 and 225.

Referring to FIG. 13, cutting guides 208, 214 and 220 consist of araised platform with a shallow groove 228 formed therein through whichthe suture passes and a deeper groove 230 formed in the platformperpendicular to the shallow groove through which a cutting tool maypass in order to cut the suture at the location lying over the deepergroove. The deeper groove is closed at one end by a stop 232 so that thetip of the cutting tool or scissors cannot pass beyond that point. Thisstop prevents the cutting tool from dipping down into the open space 234between the spokes of guide mount 150 and accidentally cutting thetissue of the patient.

When the surgeon is ready to release the suture guide from the sutureguide mount 150 he merely snips the sutures 198, 200 and 202 by passingthe cutting tool into the cutting groove of the cutting guides. When thesutures have been snipped at all three locations, the guide mount can beretrieved by pulling on the tether or otherwise removing it and sutures198, 200 and 202 are removed with the guide mount 150 since they aretied off on the guide mount.

Referring to FIGS. 14 through 18, there are shown two additionalembodiments of suture guide holders for holding a suture guide. FIGS. 14and 15 illustrate a linear suture guide holder for placing a linearsuture guide. FIGS. 16, 17 and 18 illustrate a circular or ring-shapedsuture guide holder for placing a circular suture guide.

Referring to FIG. 14, the linear suture guide holder has a detachablehandle 240 of the type shown in FIG. 2 and linear-shaped guide mount242. However, the handle embodiment with the tether illustrated in FIGS.8 and 12 could also be used. Guide mount 242 has a linear groove ortrough 244 into which suture guide 246 is fitted as shown in FIG. 15.Apertures 248 formed in guide mount 242 are used to suture the sutureguide to the guide mount as shown in FIG. 15. Guide mount 242 alsoincludes cutting guides 252 and 254 at each end of the guide mount.

Suture guide 246 is tautly secured to the linear guide mount 242 bysuture 250. One end of suture 250 is tied off at aperture 248 a, passesthrough suture guide 246 up through aperture 248 b cross cutting guide252 down through aperture 248 c through suture guide 246 up throughaperture 248 d where it is tied to a second length of suture 256. Suture256 is threaded down through aperture 248 e through suture guide 246 upthrough aperture 248 f across cutting guide 254 down through aperture248 g through suture guide 246 and up through aperture 248 h where it istied off. Thus, as in previous embodiments, when the surgeon is ready torelease the suture guide from the suture guide holder, he merely insertsthe cutting tool in the cutting grooves 252 and 254 and cuts sutures 250and 256 at that location. Suture 250 and 256 are then removed with thesuture guide mount 242. The linear suture guide shown in FIGS. 14 and 15would be used for any surgical procedure in which the incision is asubstantially straight line. The suture guide mount 242 can be anydesired length and the suture guide 246 can extend the full length ofthe suture guide mount 242 as shown in FIG. 15 or could be of a shorterlength and sutured to just a portion of suture guide mount 242. If thesurgeon desires a suture guide with a hook or curved end, the sutureguide could extend around the edge of suture guide mount 242 to provideone or two curved or hooked ends.

Referring to FIG. 16, there is shown a circular suture guide holderwhich would be useful for suturing two blood vessels or other vessels,such as intestines, together. It would also be useful for bowel andbronchial resection. The suture guide holder has a handle 260 which inthis embodiment is not shown to be detachable. However, any of thevarious handle embodiments illustrated previously could be utilized,including the tethering concepts. The suture guide mount 258 is ringshaped with a groove or trough 260 formed on the interior cylindricalsurface of the ring. The groove or trough 260 is shaped to receive acircular suture guide 261 as shown in FIG. 17. Suture guide mount 258has a plurality of apertures 262 evenly spaced about its circumferencefor use in suturing the suture guide 261 to the suture guide holder asshown in FIG. 17. Suture 264 is threaded through the apertures andthrough the suture ring in a manner similar to that described withreference to FIGS. 14 and 15 and will not be further be described inconnection with this embodiment. Suture 264 can be clipped at twolocations such as at 266 and 268 in order release the suture guide fromthe suture guide holder. Alternatively, cutting guides can be providedas shown in the embodiments previously described and illustrated.

FIG. 18 shows a cross section of the suture guide holder with the sutureguide attached thereto taken along line 18—18 of FIG. 17. FIG. 18illustrates how groove 260 engages suture guide 261 and depicts rib 263and the outer covering 265 of the suture guide.

Various shaped suture guide holders, C-shaped, linear and circular, havebeen described and illustrated in the figures, however, in accordancewith the present invention, the suture guide holder can be constructedin any desired shape depending on the surgical procedure involved. Forexample, the suture guide holder could be curvilinear for stomachreduction surgery or for certain cosmetic surgeries when it is necessaryto place a suture line along an eyelid or an ear.

While the preferred embodiments have been described, variousmodifications and substitutions may be made thereto without departingfrom the scope of the invention. Accordingly, it is to be understoodthat the invention has been described by way of illustration and notlimitation.

What is claimed is:
 1. An annuloplasty ring delivery system, comprising:an annuloplasty ring; and a rigid template defining at least a partialcircumferential edge about which the annuloplasty ring is fitted, thetemplate having one or more cutting guides formed therein adjacent thepartial circumferential edge, the annuloplasty ring being attached aboutthe circumferential edge by one or more sutures, each suture beingsecured to the rigid template, threaded through the annuloplasty ringand passed over one of the cutting guides, wherein the template can bede-coupled from the annuloplasty ring by severing each suture at therespective cutting guide.
 2. The system of claim 1, further comprising:a handle coupled to the template; a tethered connection between thehandle and template.
 3. The system of claim 2, wherein the handlecomprises a spool having a tether wound therearound, one end of thetether being attached to the template.
 4. The system of claim 3, whereinthe handle removably attaches to the template with severable sutures.5.The system of claim 1, wherein the partial circumferential edge is acircumferential groove defined by the template.
 6. The system of claim1, wherein the partial circumferential edge is a circumferential troughdefined by the template.
 7. The system of claim 1, wherein the partialcircumferential edge is a circumferential depression defined by thetemplate.
 8. The system of claim 1, wherein the partial circumferentialedge is a circumferential channel defined by the template.
 9. The systemof claim 1, wherein the partial circumferential edge is acircumferential flat surface defined by the template.
 10. The system ofclaim 1, wherein the template has a visibility window defined within thecircumferential edge for viewing a target annulus through the window.11. The system of claim 10, wherein the rigid template comprises aplanar member extending generally in a plane defined by thecircumferential edge, and wherein the visibility window comprises anopening formed in the planar member.
 12. The system of claim 11, whereinthere are a plurality of visibility windows formed in the planar memberbetween spokes extending from the circumferential edge to a centrallocation.
 13. The system of claim 12, further including a hub joiningthe spokes at the central location, wherein a handle can be attached tothe hub for manipulating the template.
 14. The system of claim 1,wherein the rigid template is generally formed in a plane, and eachcutting guide extends and has a groove formed therein such that thecorresponding suture spans the groove and a cutting tool can be insertedinto each groove to sever the sutures.
 15. The system of claim 1,further including apertures formed in the rigid template and disposed sothat the sutures extend directly therethrough into the annuloplasty ringand an outer periphery of the annuloplasty ring is un-obstructed for animplant procedure.
 16. A system of implanting an annuloplasty ring,comprising: an annuloplasty ring; and a rigid body having an outwardlyfacing surface against which the annuloplasty ring is positioned andheld in a fixed shape using at least one suture that is fixed withrespect to the rigid body, the suture passing through the ring, suchthat an outer periphery of the ring defines an outermost surface of aring/rigid body assembly, wherein the rigid body can be detached fromthe annuloplasty ring by severing the suture and removing the rigid bodyand severed suture from the secured ring.
 17. The system of claim 16,wherein the outwardly facing surface is a circumferential groove definedby the rigid body.
 18. The system of claim 16, wherein the outwardlyfacing surface is a circumferential trough defined by the rigid body.19. The system of claim 16, wherein the outwardly facing surface is acircumferential depression defined by the rigid body.
 20. The system ofclaim 16, wherein outwardly facing surface is a circumferential channeldefined by the rigid body.
 21. The system of claim 16, wherein theoutwardly facing surface is a circumferential flat surface defined bythe rigid body.
 22. The system of claim 16, wherein the rigid body has avisibility window defined within the outwardly facing surface forviewing a target annulus through the window.
 23. The system of claim 22,wherein the rigid body comprises a planar member, and wherein thevisibility window comprises an opening formed in the planar member. 24.The system of claim 23, where are a plurality of visibility windowsformed in the planar member between spokes extending from the outwardlyfacing surface to a central location.
 25. The system of claim 24,further including a hub joining the spokes at the central location,wherein a handle can be attached to the hub for manipulating the rigidbody.
 26. The system of claim 16, wherein the rigid body is generallyformed in a plane with one or more cutting guides formed therein, theannuloplasty ring being attached about the outwardly facing surface byone or more sutures, each suture being secured to the rigid body,threaded through the annuloplasty ring and gassed over one of thecutting guides, each cutting guide having a groove such that a middleportion of the corresponding suture spans the groove in a directiongenerally parallel to the plane and a cutting tool can be inserted intoeach groove to sever the sutures.
 27. The system of claim 26, furtherincluding apertures formed in the rigid body and disposed so that eachsuture extends directly therethrough into the annuloplasty ring and anouter periphery of the annuloplasty ring is un-obstructed for an implantprocedure.
 28. A system of implanting an annuloplasty ring, comprising:an assembly of an annuloplasty ring and a rigid body, the rigid bodyhaving an outwardly facing surface against which the annuloplasty ringis held using one or more sutures through the ring and into apertures inthe rigid body, the ring being positioned such that an outer peripherythereof defines an outermost surface of the ring/rigid body assembly,each suture being attached to the rigid body with a portion passingthrough the apertures and the ring, wherein the rigid body can bedetached from the annuloplasty ring by severing the suture and removingthe rigid body and severed suture from the secured ring.
 29. The systemof claim 28, wherein the outwardly facing surface is a circumferentialgroove defined by the rigid body.
 30. The system of claim 28, whereinthe outwardly facing surface is a circumferential trough defined by therigid body.
 31. The system of claim 28, wherein the outwardly facingsurface is a circumferential depression defined by the rigid body. 32.The system of claim 28, wherein the outwardly facing surface is acircumferential channel defined by the rigid body.
 33. The system ofclaim 28, wherein the outwardly facing surface is a circumferential flatsurface defined by the rigid body.
 34. The system of claim 28, whereinthe rigid body has a visibility window defined within the outwardlyfacing surface for viewing a target annulus through the window.
 35. Thesystem of claim 34, wherein the rigid body comprises a planar member,and wherein the visibility window comprises an opening formed in theplanar member.
 36. The system of claim 35, wherein there are a pluralityof visibility windows formed in the planar member between spokesextending from the outwardly facing surface to a central location. 37.The system of claim 36, further including a hub joining the spokes atthe central location, wherein a handle can be attached to the hub formanipulating the rigid body.
 38. The system of claim 28, wherein therigid body is generally formed in a plane with one or more cuttingguides formed therein, the annuloplasty ring being attached about theoutwardly facing surface by one or more sutures, each suture beingsecured to the rigid body, threaded through the annuloplasty ring andpassed over one of the cutting guides, each cutting guide having agroove such that the corresponding suture spans the groove and a cuttingtool can be inserted into each groove to sever the sutures.
 39. Thesystem of claim 28, wherein the apertures are formed in the rigid bodyand disposed so that the sutures extend directly therethrough into theannuloplasty ring and an outer periphery of the annuloplasty ring isun-obstructed for an implant procedure.